| Primary Device ID | 05055158006133 | 
| NIH Device Record Key | 2643caf5-95ff-44c3-8d84-fe20e6c7b2b3 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Elset® | 
| Version Model Number | 993483 | 
| Company DUNS | 631770658 | 
| Company Name | Mölnlycke Health Care AB | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | true | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | |
| Phone | +46737733775 | 
| pedro.lopes@molnlycke.com | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 05055158006126 [Primary] | 
| GS1 | 05055158006133 [Package] Contains: 05055158006126 Package: PACK_OR_INNER_PACK [12 Units] In Commercial Distribution | 
| GS1 | 07332551977047 [Package] Package: CASE [8 Units] In Commercial Distribution | 
| FQM | BANDAGE, ELASTIC | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-11-09 | 
| Device Publish Date | 2023-11-01 | 
| 05055158006133 | Elset 15cm x 6m x 12 | 
| 07332551976958 | Elset 10cm x 6m x 12 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ELSET  88677715  not registered Live/Pending | ELSET TECHNOLOGIES INC 2019-11-01 | 
|  ELSET  75005784  2134846 Dead/Cancelled | Accom, Inc. 1995-10-16 | 
|  ELSET  74591041  1936953 Dead/Cancelled | Seton Healthcare Group plc 1994-10-27 | 
|  ELSET  74282750  not registered Dead/Abandoned | Seton Healthcare Group plc 1992-06-05 |